DRUG DESCRIPTION

TYLENOL® with Codeine is supplied in tablet form for oral administration.

Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline
powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the
following structural formula:

C8H9NO2 M.W. 151.16

Codeine phosphate, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the following structural formula:

What are the possible side effects of acetaminophen and codeine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have any of these serious side effects:

What are the precautions when taking acetaminophen and codeine (Tylenol-Codeine)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to acetaminophen or codeine; or to other narcotic pain medications (such as morphine); or if you have any other allergies. This product may contain inactive ingredients (such as metabisulfite), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.